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US
Last updated May 27, 2026
What MACULOGIX, INC. makes
Maculogix, Inc. manufactures adaptometers, including handheld controllers, wall chargers, eye cups, headsets, head straps, and associated cables designed for visual function testing. These devices are used to assess visual adaptation and retinal sensitivity, particularly in clinical and research settings.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Maculogix, Inc. manufacture?
Maculogix, Inc. specializes in adaptometers, which are devices used to measure visual adaptation and retinal sensitivity. Their product line includes handheld controllers, wall chargers, eye cups, headsets, head straps, head strap liners, and associated cables. These devices are primarily designed for clinical and research applications to assess visual function.
Where is Maculogix, Inc. based?
Maculogix, Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries or databases list Maculogix, Inc.’s devices?
Maculogix, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the United States, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices.
How are Maculogix, Inc.’s devices classified under FDA regulations?
Maculogix, Inc.’s devices are classified as Class I medical devices under FDA regulations. This classification is typically assigned to devices posing the lowest risk to patients, often involving minimal potential harm. The classification is based on the intended use and risk profile of the adaptometers, which are primarily used for non-invasive visual testing.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 962692179
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AdaptDx Pro Handheld Controller | HC-1 | FDA UDI | Class I | Active |
| AdaptDx Pro USB-C Wall Charger International | 10870 | FDA UDI | Class I | Active |
| AdaptDx Pro Eye Cups | 10319 | FDA UDI | Class I | Active |
| AdaptDx Pro USB-C Headset Cable | 10388 | FDA UDI | Class I | Active |
| AdaptDx Pro International | 10390 | FDA UDI | Class I | Active |
| AdaptDx | Dx-04 | FDA UDI | Class I | Active |
| AdaptDx Pro Head Strap | HS-1 | FDA UDI | Class I | Active |
| AdaptDx Pro USB-C Wall Charger | 10389 | FDA UDI | Class I | Active |
| AdapDx Pro | M-1 | FDA UDI | Class I | Active |
| AdaptDx Pro Head Strap liner | 10145 | FDA UDI | Class I | Active |
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